Congenital Naevi of Lower Limb in the Child

Congenital Melanocytar Nevi in the Lower Limb Clinical Trial

— NAEVUS  

Official title:

Congenital Nevi in the Lower Limb in Children : Which Size Can be Afforded by a Simple Surgical Procedure ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04297579
• Other study ID #: RECHMPL20_0063
• Status: Completed
• Start date: January 1, 1984
• Est. completion date: May 1, 2020

Study information

• Verified date: June 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Depending on its dimensions, it is difficult to predict if a congenital nevi of the lower limb can be surgically removed by a unique simple procedure or by a complex procedure (expander, skin graft etc..), with a good result.

This study retrospectively reviewed the practice of our team of surgeons depending on the size of the naevus to reveal a dimension threshold that can be used in the future to help to choose between a simple or a complex procedure.

Description:

Retrospective study using medical file data only. No intervention nor phone call etc.. to the patients or their parents.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: May 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion criteria:

• Child + congenital nevi in the lower limb + had removal surgery

Exclusion criteria:

• More than one congenital nevi in the lower limb.

Related Conditions & MeSH terms

• Congenital Melanocytar Nevi in the Lower Limb
• Nevus

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nevi Estimated Size	Nevi Estimated Size (centimeters)	within three weeks after surgery
Secondary	post-operative complications depending on the initial size of the naevus	post-operative complications depending on the initial size of the naevus : percentage of complication rate	assessed within 6 months after surgery